FDA 510(k) Application Details - K193655

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K193655
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Self Doctor Care, LLC 8811 Teel Pkwy Ste 100, Unit 6141 Frisco, TX 75036 US Other 510(k) Applications for this Company
Contact	Wei Wei Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2019
Decision Date	09/04/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review